In this Fast-Track application, PlastiPure (PPi) proposes to rapidly and completely develop for commercialization an EA-Free baby bottle to address an important public health problem: ingestion by infants of chemicals having estrogenic activity (EA) or anti-EA leaching from multiple components of baby bottles, including the bottle, anticolic devices, nipple, sealing rings, etc. Many scientific studies have shown that chemicals having EA or anti-EA can have significant adverse health effects on many biological processes such as sperm number and function, prostate size, uterine and ovarian functions, time to puberty, obesity, learning abilities, and some types of cancers. These adverse health effects sometimes occur at very low (pM-nM) concentrations, especially on fetal or developing mammals (including humans). Many scientific studies have also shown that bisphenol A (BPA) has EA and leaches from hard and clear polycarbonate (PC) plastics at nM-<M concentrations that have adverse health effects on fetal or juvenile mammals. PPi's studies show that almost all plastics, including BPA-free plastics and most components of all plastic baby bottles, release other chemicals having EA often at levels higher than PC plastics. PPi will use its unique and patented materials and manufacturing processes to produce baby bottles whose component parts do not release any chemical having EA or anti-EA, i.e., are EA-Free even when exposed to common-use stresses (UV light, microwaves, moist heat). In Phase I, PPi will confirm preliminary data that that it is feasible to develop EA-Free silicones to manufacture EA-Free nipples for baby bottles. In Phase II, PPi will confirm that it has EA-Free resins to make all other components of EA- Free baby bottles, including hard and clear resin substitutes for PC bottles, that meet or exceed fit-for-use tests and remain EA-Free, both as new bottles and after repeated test cycles simulating extended use. PPi's EA-Free baby bottles will be unique in the industry and provide significant health benefits to our most vulnerable populations: fetus, infants and juveniles. Because it has already developed most of the materials, PPi is uniquely positioned to begin work immediately and put advanced-technology, safer products on retail shelves within 21/2 years. As breakout products, EA-Free baby bottles will achieve rapid market penetration and raise consumer awareness about the safety of plastic products in general. The success of these baby bottles will allow PPi to introduce safer EA-Free plastics into a broad range of food packaging and consumer goods, greatly increasing overall consumer product safety. Using PPi's unique and patented EA-Free plastic materials and processing methods to produce EA-Free baby bottles directly and decisively fulfill NIEHS' (and PPi's) mission to reduce the burden of human illness and disability. PUBLIC HEALTH RELEVANCE: PlastiPure (PPi) is addressing a public health problem [release of chemicals having estrogenic or anti-estrogenic activity (EA or anti-EA) ingested by infants using plastic baby bottles] by using its unique and patented materials and methods to produce baby bottles that do not release chemicals having EA or anti-EA. Chemicals having EA or anti- EA, even at very low dosages on fetal mammals, can have significant adverse effects on many behavioral and physiological processes such as sperm counts, uterine and ovarian functions, aggressive behaviors, and some types of cancers. EA-Free baby bottles decisively fulfill PPi's and NIEHS' mission of reducing the burden of human illness and disability.